Pharmacovigilance Manager
Вакансия № 5038777 от компании VALEANT на Электронной Службе Занятости Населения Москвы.
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☑ Основной блок:
Опыт работы: 3–6 лет.
Тип занятости: полная занятость.
График работы: полный день.
Зарплата: по результату собеседования.
Примерное место работы: Россия, Москва.
☑ Актуальность объявления:
Это объявление № 5038777 добавлено в базу данных: Среда, 12 февраля 2025 года.
Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.
☑ Статистика предложения работы № 5038777:
Прочитано соискателями - 225 раз(а);
Отправлено откликов - 1 раз(а);
☑ Репутация компании "VALEANT":
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☑ Подробности о вакантном месте:
- To coordinate day-to-day management of the pharmacovigilance local system in Eurasian Markets Region (EMR) and ensure local compliance with applicable Regulations and Corporate policies (local and global)
- To act as Deputy National Responsible Person in terms of EU Directive 2010/84/EС and local legislation
- To facilitate Pharmacovigilance training at a local and regional level (as applicable)
- To support Safety Data Exchange Agreement (SDEA) preparation and updates
Responsibilities:
- Responsible for local Pharmacovigilance System (EMR)
- To ensure all local affiliate responsibilities are fulfilled as documented globally and in the PSMF
- Intake, if applicable translate, and forward Adverse Events regarding pharmaceuticals and medical devices for processing within the Global Pharmacovigilance and Risk Management (GPRM) team, ensuring all cases are processed in a timely manner
- Perform/manage reconciliation of Adverse Events for EMR
- Prepare and manage local SOPs and written procedures according to local legislations and in line with Pharmacovigilance global SOPs
- Ensure that local pharmacovigilance system is managed with local SOPs
- Preparation and updating of SDEAs
- Acting as the local Pharmacovigilance (PV) contact person for local health authorities and for the EU QPPV, as required
- Support compilation of aggregate reports by providing requested EMR specific data
- Participate in global PV training activities
- Manage PV training for local affiliate employees incl. sales representatives as applicable
- Support labeling update activities
- Support Direct Healthcare Professional Communication and other risk minimisation measures, if applicable
- Perform/organize local literature search (journals not listed in EMBASE); maintain, check and update list, documentation of local literature search
- Keep senior managers updated of changes in local responsible persons
- Keep local PV SOP updated on a regular basis
- Act as local contact point for audit and inspections and related processes, including the preparation and maintenance of Inspection Binder
- Support review of local agreements and compliance
- To ensure appropriate archiving of relevant documentation and correspondence
- To represent GPRM and the company in an ethical and positive manner
- Work independently and responsibly in occasional work from home environment
Qualifications:
- Degree in Medical Science strongly preferred or Pharmacist, Life Sciences degree
- Knowledge of EMR laws and guidelines related to medicinal products and medical devices
- Good spoken and written English knowledge, including medical terminology
- Basic computer literacy, including Excel and PowerPoint
- Analytical thinking and problem-solving skills
- Excellent interpersonal and presentation skills
- Strong patient orientation
- Minimum 2-4 years of working experience in pharmaceutical industry
- Minimum 2-4 years of experience performing the functions of pharmacovigilance or materiovigilance, including review and reporting of adverse events, communication with Health Authorities/notified bodies
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